Clinical Trials Directory

Trials / Completed

CompletedNCT05024331

A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor

A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor : Data Collection and Model Validation

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Samsung Medical Center · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Accepted

Summary

This study aims to compare and evaluate the predicted values of the participants, and the algorithm predicted values of ANC level reduction periods after high-capacity chemotherapy in pediatric solid tumor patients. The participants are pediatricians who voluntarily participate in this study and consent to this study.

Detailed description

n pediatric patients with solid tumors, chemotherapy for radical treatment is generally based on monitoring white blood cells, red blood cells, and platelets with repeated blood tests during treatment due to bone marrow depression. Early blood culture and experiential intravenous antibiotics are required to prevent progression to sepsis if fever or other infection signs are accompanied by a decrease in absolute neutrophil count (ANC) below 500/mm3. In addition, repeated blood transfusions are needed to keep the appropriate levels constant depending on clinical symptoms in platelet reduction or anemia. In particular, in the case of high-dose chemotherapy conducted on high-risk tumors, anticancer drugs are given over the dose expected to recover natural bone marrow function to improve the treatment performance of tumors responding to chemotherapy. Moreover, it is challenging to recover naturally after high-dose chemotherapy so that the collected in advanced hematopoietic stem cells are implanted into the patient to support ANC level recovery. However, despite the transplantation of these self-hematopoietic stem cells, some patients need long-term continuous blood transfusions due to delayed hematological recovery and may need long-term hospitalization to treat accompanying infections and complications. The researcher developed a model that can predict the suppression and hematological recovery of bone marrow after high-capacity anticancer drugs by analyzing blood tests and blood transfusions repeatedly from the diagnosis of pediatric solid tumors after high-capacity chemotherapy collected from 2000-2018.

Conditions

Timeline

Start date
2021-07-30
Primary completion
2021-07-30
Completion
2021-08-12
First posted
2021-08-27
Last updated
2021-09-13

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05024331. Inclusion in this directory is not an endorsement.